We've updated our Privacy Policy to make it clearer how we use your personal data. We use cookies to provide you with a better experience. You can read our Cookie Policy here.

Advertisement

European Commission Approves Frontline Induction Therapy before Stem Cell Transplantation

Listen with
Speechify
0:00
Register for free to listen to this article
Thank you. Listen to this article using the player above.

Want to listen to this article for FREE?

Complete the form below to unlock access to ALL audio articles.

Read time: Less than a minute

Janssen-Cilag International NV (Janssen) announced that the European Commission (EC) has approved the use of VELCADE® (bortezomib) as induction therapy (a first therapeutic option) in combination with dexamethasone (VD) or thalidomide and dexamethasone (VTD).1 This licence extension will apply to adult patients with previously-untreated multiple myeloma who are eligible for high-dose chemotherapy with haematological stem cell transplantation.

Until now, VELCADE’s (bortezomib) indication has been limited to its use, in combination with melphalan and prednisone, in adult patients with multiple myeloma that are previously untreated and ineligible for stem cell transplant, and as a single agent in advanced multiple myeloma.2 Multiple myeloma, a type of blood cancer, currently affects around 60,000 people in Europe.3 This decision could mean significantly improved outcomes for many patients with this disease.

The approval by the EC was based on the analysis of data from two Phase III trials (IFM-2005-01, PETHEMA/GEM05) which demonstrated that treatment with VELCADE-based induction resulted in improvements in post-induction and post-transplant response rates and in progression-free survival (PFS); PFS and overall survival (OS) were secondary endpoints.

The trials studied the use of VELCADE-based regimens VD and VTD, compared to non-VELCADE-based regimens of vincristine plus doxorubicin and dexamethasone, or thalidomide and dexamethasone, respectively, as induction therapy prior to autologous stem cell transplant in adult patients with previously-untreated multiple myeloma.